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FEDERAL REGISTER · NOTICESeptember 17, 2025NOTICE — NO LEGAL EFFECT

Disseminated Coccidioidomycosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

Document type
Notice
Agency
Health and Human Services Department
Published
September 17, 2025
Comments close
November 17, 2025
Document number
2025-18002
ABSTRACT

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Disseminated Coccidioidomycosis: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of disseminated coccidioidomycosis caused by Coccidioides species (i.e., C. immitis and C. posadasii).

Abstract as published in the Federal Register.

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